FLUYT-prevent trial

• Register: ISRCTN
• Last refreshed on: 12 April 2021
• Main ID: ISRCTN13659155
• Date of registration: 18/05/2015
• Prospective Registration: Yes
• Primary sponsor: Radboud University Medical Center
• Public title: FLUYT-prevent trial
• Scientific title: Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis
• Date of first enrolment: 05/06/2015
• Target sample size: 826
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13659155
• Study type: Interventional
• Study design: Multicenter randomized superiority trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Erwin van Geenen

Key inclusion & exclusion criteria

Inclusion criteria:
1. Requiring ERCP
2. Between 18 and 85 years of age
3. Signed informed consent

Exclusion criteria:
1. Allergy to NSAIDs or other contraindications
2. Ongoing acute pancreatitis
3. Ongoing hypotension, including those with sepsis
4. Cardiac insufficiency (CI, >NYHA Class I heart failure)
5. Renal insufficiency (RI, creatinin clearance <40ml/min)
6. Active ulcer disease
7. Severe liver dysfunction: liver cirrhosis and ascites
8. Respiratory insufficiency (pO2<60mmHg or 90% despite FiO2 of 30% or requiring mechanical ventilation)
9. Pregnancy
10. Hyponatremia (Na+ levels < 130mmol/l)
11. Hypernatremia (Na+ levels > 150mmol/l)
12. Oedema
13. Low risk of PEP: chronic calcific pancreatitis (PD intervention is allowed) or pancreatic head mass or routine biliary stent exchange or re-ERCP with a history of endoscopicsphincterotomy with a CBD intervention (PD intervention is allowed)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Choledocholithiasis and other conditions requiring endoscopic retrograde cholangiopancreatography (ERCP)
Digestive System
Choledocholithiasis

Intervention(s)

High volume intravenous hydration with lactated Ringer's solution

Added 17/02/2017:
Partcipants are randomised to one of two treatment arms:
1. Control group: 100mg rectal NSAID + no or mild hydration with normal saline (max 1.5mL/kg/hr, max. 3L/24h)
2. Intervention group: 100mg rectal NSAID + hydration with lactated Ringer’s solution (20mL/kg <60min, starting at the beginning of ERCP (scope-mouth contact), followed by 3mL/kg/hr for 8 hours)

Patients are discharged after ERCP after a minimal clinical stay of 24 hours. It is at the discretion of the treating physician whether an admission or longer monitoring is indicated. All patients are followed up for 180 days after randomization.

Primary Outcome(s)

Post-ERCP pancreatitis, according to Cotton criteria

Secondary Outcome(s)

1. Severity of post-ERCP pancreatitis measured at discharge (Cotton criteria)
2. Severe morbidity (Atlanta criteria) or death measured at discharge
3. ERCP related complications within 48 hours after ERCP
4. Fluid hydration related complications within 24 hours after ERCP or at the latest at discharge
5. Length of hospital stay (including stay on the intensive care unit) measured after a follow up period of 6 months (so readmissions can be taken into account)
6. Direct and indirect costs measured after 6 months of follow up
7. Risk factors for developing post-ERCP pancreatitis measured at baseline
8. Generic health-related quality of life measured with EQ5D and SF36
9. Exocrine and endocrine pancreatic insufficiency at 180 days: fecal elastase-1 and HbA1c
10. Incidence of delayed post-ERCP pancreatitis

Secondary ID(s)

Version 2 (dated 09/03/2015)

2015-000829-37

Source(s) of Monetary Support

Radboud University Medical Center, Department of Gastroenterology and Hepatology, Netherlands Organisation for Health Research and Development

Ethics review

Status:
Approval date:
Contact:

On the 14/04/2015, the Medical research Ethics Committees United (MEC-U) gave a positive verdict for the trial. Also, as a Competent Authority for the review of clinical trials in the Netherlands, the CCMO has performed a marginal assessment of the clinical trial. The Competent Authority found no objection against execution of the trial within the Netherlands. This verdict was given on 06/05/2015.

Results

• Results available: Yes
• Date Completed: 03/12/2019